Devices and methods for enhancing bone growth

ABSTRACT

The present invention is generally related to implants for compensating bone loss in mammalian body, and to devices and methods for replacing or creating facial bone. The present invention relates to devices and methods for implanting an implantable device in a subject&#39;s body. The implantable device embodying features of the present invention include a body formed from a rig or matrix having a trabecular meshwork structure or cells with shapes suitable for a particular anatomical area of interest. The device may be a dental implant serving as a platform for placement of dental crowns.

CLAIM OF PRIORITY

This application claims the benefit of priority to U.S. patentapplication Ser. No. 13/335,371, filed Dec. 22, 2011, entitled “DEVICESAND METHODS FOR ENHANCING BONE GROWTH”, which is incorporated herein byreference in its entirety.

FIELD OF THE INVENTION

The present invention is generally related to implants for compensatingbone loss in the mammalian body, and more particularly, and for exampledevices and methods for replacing or creating facial bone.

All patents and published patent applications referred to herein areincorporated by reference in their entirety.

BACKGROUND

Bone loss is a phenomenon that may occur for any number of reasonsduring one's life (whether human, mammal, or any other vertebrate).Dental implants are fixtures of metal, typically titanium alloy, whichare surgically screwed into the jawbone, often for replacing missingteeth. In the case of a dental implant, the implant is an anchor for anaturally-appearing false tooth or a set of false teeth. The successrate of dental implants depends on where and how the implants are placedand their purpose. It is important that the subject has enough bone inthe area of the missing tooth/teeth for the implants to be attached to.Implants are used to replace single, multiple or all teeth. Implants areincreasingly being used to replace fixed bridges and removable partialor full dentures.

For a patient who is missing one or more of his/her teeth, implants maywell be an option for candidate as long as the patient has enough bonein the area of the missing tooth/teeth to facilitate the anchorage ofthe implants. If the patient does not have enough bone for this purpose,a bone graft may be necessary. Dental implants are alternatives to fixedbridge, a removable partial dentures or removable full dentures.

The typical implant procedure is a surgical placement of the implant orimplants in the patient's jawbone which requires a three to six monthshealing period before the implant restoration (crown) can be placed.During this healing time, the bone grows in and around the titaniumimplant creating a very strong support. Although the rejection orfailure rate of dental implants is low, in the event such rejectionhappens, the implant is replaced with another implant of a slightlylarger size or do bone graft and place another implant

When missing one tooth, the cosmetic dentist may use a flipper to fillthe space. A flipper is a false tooth to temporarily take the place of amissing tooth before the permanent crown is placed on the implant. Aflipper can be attached via a wire or an acrylic base that fits on theroof of the mouth. Flippers are meant to be a temporary solution whileawaiting the permanent crown to be placed on the implant(s).

There are many implants available, each designed for a specificfunction. Most are made of titanium alloy, an inert metal which has beenproven to be effective at fusing with living bone, a process known asosseointegration.

Sometimes, when resorption has excessively reduced the jawbone, it canbe rebuilt through modern bone grafting techniques. Bone grafts canbuild up or fill in jawbone defects allowing the placement of dentalimplants.

In the single surgery method the dentist will order a special CAT scanof the patient's jawbone. Using the CAT scan data and advanced computermodeling techniques, a model of the jawbone is constructed. This modelis used by a dental laboratory to fabricate the custom subperiostealimplant to fit the subject's jaw. A surgical procedure is then carriedout where the jawbone is exposed and the implant placed. The gums areclosed with several stitches and the replacement teeth are placed on theabutments of the subperiosteal implant.

Despite the advances in dentistry and implant procedures, there is roomfor further improvement in providing enhanced devices and methods formore timely placement of implants, in particular dental implants.

SUMMARY OF THE INVENTION

The present invention relates to devices and methods for implanting adevice in a patient's body. In an embodiment, the implantable deviceembodying features of the present invention include a body formed from arig having a trabecular meshwork structure with shapes suitable for aparticular anatomical area of interest. In an embodiment, the device isa dental implant serving as a platform for placement of dental crowns orbridges. In an embodiment, the present devices and methods enhance thegrowth of bone, as for example, the mandibular bone. In an embodiment,the growth is new bone growth where for any number of reasons, theoriginal bone was either lost or never existent. Provided herein is animplantable device comprising a 3 dimensional trabecular meshworkstructure having a length, a height, a width, a first end, and a secondend, at least one fixating surface for receiving a fixating element foroperatively attaching the rig to the bone and at least one cap receivingsurface for receiving one or more caps thereon. In some embodiments ofthe device, the length of the structure is nominally defined by adistance between the first end and second end of the structure, andranges from about 5 mm to about 200 mm. In some embodiments of thedevice, the height of the structure is nominally defined by a distancebetween a lower rim and an upper rim of the structure, and ranges fromabout 1 mm to about 60 mm. In some embodiments of the device, thestructure is formed from a plurality of cell structures. In certainembodiments of the device, the plurality of cell structures comprises amatrix having a depth and height which ranges from about 1 to about 9cells, and from about 9 to about 1 cell, respectively. In someembodiments of the device, each cell has an inner surface area rangingfrom about 50 microns to about 10 mm. In other embodiments of thedevice, the ratio of the total inner area of the cells to the totalsurface area of the structure ranges from about 10% to about 90%. Insome embodiments of the device, the lower rim of the structure includesat least one bone fixation surface. In certain embodiments of thedevice, at least one cap receiving surfaces include at least oneabutment receiving surface for receiving a crown thereof.

Also provided is a method for implanting a device in a patient's body,comprising identifying a patient suitable for receiving an implant suchas a dental implant, commissioning a three dimensional image of a targetarea of the patient's body for receiving the implant, commissioning adesign of the implant using computer modeling, commissioning theconstruction of the implant using deposition method, and affixing theimplant within the patient's body. In some embodiments of the method,the image is procured using CT scan. In other embodiments of the method,the implant is constructed using a 3D laser printing techniques by 3DLaser Sintering Printing. In certain embodiments of the method, theimplant is constructed from a bio-compatible material. In someembodiments of the method, the bio-compatible material comprises atleast one of titanium alloy or zirconium. In an embodiment, the implantmaterial of the present invention is non-porous or substantiallynon-porous. In an embodiment, the surface of the implant is textured inareas where bone growth is desirable to maximize the surface between thebone and the rig. In an embodiment, where the abutment emerges throughthe soft tissue, the implant surface is smooth to minimize undesirablebacteria collection at the soft tissue level (e.g., gum level).

In other embodiments of the method, the implant is a dental implant andthe affixing of the implant within the patient's body comprisesreflecting a gum of the patient to expose a bone area suitable forreceiving the dental implant, disposing a dental implant on the bonearea, the dental implant comprising a rig having a three (3) dimensionaltrabecular meshwork structure having a length, a height, a width, afirst end, and a second end, at least one fixating surface for receivinga fixating element to operatively attach the rig to the patient and atleast one cap receiving surface for receiving one or more caps thereon.In an embodiment the rig has a plurality of cells forming the meshworkand facilitating the fixation of the dental implant to the patient'sbone. In certain embodiments, the method further comprises applying bonegraft substance to the plurality of the cells. In some embodiments, themethod further comprises disposing at least one permanent abutment on apre-determined portion of the cap receiving surface fixating the gum inplace, and disposing one or more caps on the at least one permanentabutment. In other embodiments of the method, disposing of the permanentabutment occurs during at least substantially the same surgicalprocedure as the disposing of the rig in the patient's mouth. In someembodiments of the method, disposing of the permanent abutment occurs ina substantially subsequent surgical procedure following the disposing ofthe rig in the patient's mouth after the passage of a period of time. Incertain embodiments of the method, the subsequent surgical procedurecomprises, disposing healing abutments onto the rig, and allowingpassage of time before disposing the permanent abutment step.

The rig being a three dimensional structure, includes several sides,surfaces, and/or ends, herein described relative to a patient's mouthonce implanted therein. It should, however, be appreciated by thoseskilled in the art that such relative positional references are for easeof reference.

In an embodiment, the rig includes a length, a height, a width, a frontend or edge, and a back end or edge, an outer surface, and an innersurface. These nouns describing the various parts of the device are usedfor ease of reference and are as defined by the present inventor. By wayof example, as used herein and as positioned in the lower jaw of apatient's mouth, the front end refers to the side closest to thepatient's front teeth; back end refers to the end opposite the frontend; outer surface refers to the side of the device facing the cheek ofthe patient; the inner surface refers to the side of the device oppositethe outer surface; the length refers to the dimension extending from thefront end (toward the front tooth) to the back end (toward the molartooth); height refers to the dimension extending vertically from thesurface adjacent the lower jaw toward the roof of the mouth; widthrefers to the dimension extending between the outer surface and theinner surface. It should be noted that although the present invention isbeing described relevant to a dental implant and process for making andusing the same, that such devices and methods are not limited to thedental applications and may be used in any other anatomical structuresuffering from some, substantial, or complete bone decay or bone loss,or insufficient bone mass.

The length of the structure may nominally be defined by a distancebetween the first end and second end (or rim) of the structure, andranges from any amount to fit within a patient's mouth. For example, therange of length may be from about 5 mm to about 200 mm. In otherembodiments of the device, the height of the structure may be nominallydefined by a distance between a lower rim and an upper rim (or loweredge and upper edge) of the structure, and ranges from any amount to fitwithin a patient's mouth. For example, the range of height may be fromabout 1 mm to about 60 mm. In some embodiments of the device, thestructure may be formed from a plurality of cell structures. In certainembodiments of the device, the plurality of cell structures comprises amatrix having a depth and height which ranges from any amount to fitwithin a patient's mouth. For example, the range of depth and height maybe from about 1 to about 9 cells. The range of depth and height mayalso, for example, range from about 9 to about 1 cell. In otherembodiments of the device, each cell has an inner surface area rangingfrom any amount to fit within a patient's mouth. For example, the innersurface area range may be from about 50 microns to about 10 mm. In otherembodiments of the device, the ratio of the total inner area of thecells to the total surface area of the structure may range from anyamount to fit within a patient's mouth. For example, the ratio of thetotal inner area of the cells to the total surface area of the structuremay range from about 10% to about 90%.

The matrix, having a plurality of cell structures, may also be referredto as a rig, platform, device, implant, mesh network, meshwork,scaffolding, structure, metallic bridge, plate, or combinations thereof.The matrix may also be made of any type of suitable material.

The implant includes at least one bone fixation feature for beingoperatively attachable to a bone surface of the patient. The implantabledevice, in an embodiment, includes at least one cap (or similarcoverings including crowns) receiving surface for receiving one or morecaps (and/or crowns or similar objects) thereon.

The healing period for any method or procedure described herein may varyfrom patient to patient and can be of any length of time. For example,the healing period can be two weeks, one month, six weeks, two months,ten weeks, three months, fourteen weeks, four months, eighteen weeks,five months, twenty-two weeks, six months, twenty-six weeks, sevenmonths, thirty weeks, eight months, thirty-four weeks, nine months,thirty-eight weeks, ten months, forty-two weeks, eleven months,forty-six weeks, and a year.

In an embodiment, the implants and methods using the same, provide for asingle or a multi-step process (e.g., periods of delay in betweentreatments and/or separate surgical procedures). In an embodiment, theimplants and methods embodying features of the present invention providefor relatively immediate placement of the implant configured forintegration with the patient's bone within the body, and in particular,in areas having bone deficiency. In an embodiment, the implants andmethods embodying features of the present invention comprise amulti-step process where there are periods of delay and healing inbetween separate surgical procedures.

By way of example, in the case of the rig being implanted in the lowerjaw of the patient, at least the lower edge, surface, or rim willinclude the bone fixation surface for affixation of the device to thelower jaw of the patient. The rig, at its front and/or back ends, mayalso include at least one or more bone fixation surface.

The rig may include, at the top edge or surface or rim (as for examplethe edge opposite the lower jaw bone and directed toward the roof of themouth), a cap (or crown) receiving surface. The cap-receiving surface isconfigured for securely receiving thereon a cap or similar device, suchas a dental crown.

In an embodiment, the rig at the upper surface includes at least oneabutment surface, disposable between the rig and the cap, for receivingthe dental cap thereon. The at least one abutment surface may besplinted rigidly as one piece with the rig or attachable to the rig bysuitable means and structures including but not limited to adhesives,male/female attachments, screws and the like.

The rig may be custom designed using any number of suitable means suchas three dimensional (3D) modeling software to fit the particularanatomical area of interest such as an edentulous area of the specificpatient. Such design may be carried out upon imaging of the patient'sanatomical area of interest using techniques and tools such as CT scanof the jaw. Upon completion of the design of the rig, the virtual designmay be transformed into a physical structure/rig by way of suitabletechniques such as 3D Laser Sintering printers, such as those availablefrom Materialise, 3D systems.

In some embodiments of the method, the bio-compatible material may be ofany type, percentage composition, combination, purity, strength and thelike. The bio-compatible material may be of general biocompatibility,immunological biocompatibility, or bio-energetic biocompatibility. Anytype of biocompatible material may be used, for example, compositefilling, porcelain, aluminum oxide, gallium alloys, non-allergenic ornon-toxic metals, amalgam, alloy, direct composite, indirect compositeinlay/onlay, porcelain inlay/onlay, gold inlay/onlay, titaniuminlay/onlay, gold or silver, non-precious alloys, zirconium oxide,titanium, and combinations thereof.

In an embodiment, the rig includes cavities or cells defined by aplurality of girders which in turn form a truss. The bone matter mayfill in the cavities over time. In an embodiment, the rig is configuredto include a relatively higher cavity or cell surface area to implantsurface area for enhanced subsequent integration with the patient'sbone. In an embodiment, the rig may be hyroxyapatite coated, plasmasprayed, or etched (e.g., chemically etched) to provide the increasedbone/implant surface.

Rigs constructed according to the present invention, provide forenhanced bone conduction. The rigs employed as scaffolding structures,allow autogenous, allograft, and or xenograft bone graft substance orbone morphogenic protein to grown in and around the rig to replace themissing bone.

In an embodiment, the rig may be affixed to the bone, e.g., jaw bone, bysuitable means such as screws, wires, intrusions into the jaw bone bydrilling specific osteotomies to allow certain parts of the rig toendosseously integrate with the patient's body. In an embodiment, therig will, in time, become a part of the patient's body as bone growsinside and around the rig's mesh-like structure.

The implants embodying features of the present invention may beimplanted as a single stage implant procedure. In an embodiment, theabutments (or abutment surfaces) can be splinted as one part of the rig.Transitional or permanent prosthesis may also be disposed on the sameday of the procedure.

In an embodiment, the rig may be placed initially in the patient'smouth, separated, from permanent abutments. In this embodiment, the rigmay be placed in the mouth along with healing screws. This configurationmay allow the bone to grow and integrate with the rig and to be coveredat least substantially with soft tissue. Thereafter, after passage ofsufficient time (e.g., 6 months), during the next stage of theprocedure, healing screws are removed and healing abutments are placedin the rig to allow the placement of permanent abutments and prosthesisat, preferably, a later time.

The rig may be covered with resorbable or non-resorbable membrane,connective tissue, pericardium membrane, alloderm graft, or any othersuitable material held in soft tissue coverage and to allow for asufficiently effective protection of the rig and the bone graft.

As indicated earlier, the rig may be used in other implantreconstructive procedures in other suitable areas of the jaw or theanatomy all together, where bone will be necessary or useful to grow incertain shape, form, and/or volume. By way of example and notlimitation, such other modalities include orthopedics, plastic surgery,oral and maxillofacial surgery, ENT (ear, nose, throat), or any otheranatomical area and procedure which may benefit from the devices andmethods of the present invention.

The above and other features of the present invention, which will becomemore apparent as the description proceeds, are best understood byconsidering the following Detailed Description in conjunction with theaccompanying drawings, wherein like characters represent like partsthroughout the several views.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting and non-exhaustive features of the present invention aredescribed with reference to the following figures, wherein likereference numerals refer to like parts throughout the various figures.

FIG. 1A is a simplified illustration of a patient undergoing imagingprocedure.

FIG. 1B is a simplified illustration of the process for capturing theimage of the patient's mouth and fabricating an implantable devicehaving the features of the present invention.

FIGS. 2A and 2B are simplified illustrations of an implantable deviceembodying features of the present invention disposed within a patient'smouth.

FIG. 3 is a simplified illustration of a process for exposing apatient's jaw bone by reflecting the gums and oral mucosa covering thebone.

FIG. 4 is a simplified illustration of a step in a process for disposingan implantable device embodying features of the present invention in apatient's mouth, showing the disposal of a surgical guide in thepatient's mouth.

FIGS. 5 and 6 are a simplified illustrations of steps in a process fordisposing an implantable device embodying features of the presentinvention in a patient's mouth, showing the disposal of a device in thepatient's mouth.

FIG. 7 is a simplified illustration of a step in a process for disposingan implantable device embodying features of the present invention in apatient's mouth, showing the application of bone graft substance ontoand/or within cavities of the device.

FIG. 8 is a simplified illustration of a step in a process for disposingthe device of FIG. 7 in a patient's mouth, showing the suturing of theflap.

FIG. 9 is a simplified illustration of a step in a process forimplanting the device of FIG. 8 in a patient's mouth, showing theremoval of healing screws and placement of healing abutments.

FIG. 10 is a simplified illustration of a step in a process forimplanting the device of FIG. 9 in a patient's mouth, showing healingabutments in place.

FIG. 11 is a simplified illustration of a step in a process forimplanting the device of FIG. 10 in a patient's mouth, showing theremoval of healing abutments.

FIG. 12 is a simplified illustration of a step in a process forimplanting the device of FIG. 11 in a patient's mouth, showing theplacement of crowns.

FIG. 13 is a simplified illustration of a step in a process fordisposing an implantable device embodying features of the presentinvention in a patient's mouth, showing the application of bone graftsubstance onto and/or within cavities of the device, with abutmentsbeing integrated with the rig.

FIG. 14 is a simplified illustration of a step in a process forimplanting the device of FIG. 13 in a patient's mouth, showing thesuturing of the soft tissue flap.

FIGS. 15A and 15B are simplified side views of steps in a process forreplacing bone and restoring function when the whole body of mandible orwhole segment of the mandible is missing due to various reasons such ascancer, gunshot, facial trauma, etc.

FIGS. 16A and 16B are front views of illustrations of FIGS. 15A and 15B.

FIGS. 17A and 17B are top views of illustrations of FIGS. 15A and 15B.

FIGS. 18A and 18B are simplified front views of steps in a process forrestoring the aesthetic and function in atrophic jaw where all the teethare missing.

FIGS. 19A and 19B are side views of illustrations of FIGS. 18A and 18B.

FIGS. 20A and 20B are top (occlusal) views of illustrations of FIGS. 18Aand 18B.

DESCRIPTION OF THE DRAWINGS

The present invention relates to devices and methods for implanting animplantable device in a patient's body. In an embodiment, the device isa dental implant serving as a platform for placement of dental crownsand/or caps and/or fixed or removable prosthesis.

Features of an exemplary device and method for implanting the same,after it has been fabricated as described earlier, will be explained inreference to the following figures. It should be noted that either orboth process and apparatus elements may be intended when referring tothe following figures.

Now referring to FIGS. 1A and 1B, a patient 10 is identified needing adental implant. In an embodiment, the patient suffers from total orsubstantial bone loss in the jaw. The physician commissions a threedimensional image 11 of the patient's anatomical area of interest usinga 3D scanning tool 130. The anatomical area of interest may be thepatient's mouth requiring such implant. The image and relatedinformation may be captured on a data storage 160, either local orremote to the scanning tool. The image and related information may bedisplayed on a display 190 with a keyboard 210 providing the means fordata and instructional communication between an operator and thescanning tool 130.

Once the image has been scanned, the image is used to create a virtualimplantable device. The commissioning and design, as for example shownin 13 of FIG. 1B, of the suitable implant may include the use of anyappropriate tool including computer modeling.

The fabrication of the implant is then commissioned, as for exampleshown in 15 of FIG. 1B. The virtual implantable device is thereafterused to create a 3D implantable device 500 (as shown in FIGS. 2A and2B), using techniques such as 3D laser printing. The implant may befabricated using other suitable methods, including, but not limited to,deposition or casting. As shown, a 3D laser printer 17 used to fabricatethe implantable device 500.

3D printing is a form of additive manufacturing technology where a threedimensional object is created by laying down successive layers ofmaterial. 3D printers are generally faster, more affordable and easierto use than other additive manufacturing technologies. 3D printers offerproduct developers the ability to print parts and assemblies made ofseveral materials with different mechanical and physical properties in asingle build process. Advanced 3D printing technologies yield modelsthat can serve as product prototypes. Using techniques and equipmentsuch as 3D laser printers, great resolution, accuracy, and precision inthe fabrication of the desired object can be obtained.

Thereafter, after appropriate examination of the fabricated implant, theimplant using methods embodying the present invention will be affixedwithin the patient, e.g., patient's mouth.

Now referring to FIGS. 2A and 2B, an exemplary implantable device 500 isshown as disposed in a subject's mouth.

In an embodiment, the implantable device 500 includes a trabecularmeshwork structure such as a rig 513 having a length 516, a height 519,a width 521, a front edge (or rim) 524, and back edge 527, an outer edgeor surface 535, and an inner edge or surface 533. The rig 513 includespluralities of girder-like structures 514 defining a plurality ofcavities 515 therebetween. It should be noted that the term girder-likeis not intended to be limited to elements which may form traditionaltriangular truss structures or elements and the network may take anysuitable form or geometry as for example, the truss-like structureshaving curved elements such as struts in a cardiovascular stent. Itshould further be noted that the nouns describing the various parts ofthe device are used for ease of reference and are as defined by thepresent inventor. By way of example, as used herein and as positioned inthe lower jawbone 16 of a patient's mouth, the front edge 524 refers tothe side closest to the patient's lips; back edge 527 refers to the edgeopposite the front edge; outer edge surface 535 to the side of thedevice facing the cheek of the patient; the inner surface 533 refers tothe side of the device opposite the outer surface; the length 516 refersto the dimension extending from the front edge (e.g., front teeth 525)to the back edge 527 (toward the molar tooth); height 519 refers to thedimension extending vertically in the direction from the lower jawtoward the roof of the mouth; width 521 refers to the dimensionextending between the outer surface and the inner surface. It should beappreciated, however, that the devices of the present invention are notlimited by these nouns and are adaptable for use in any suitable part ofthe mount or other anatomical areas of the patient.

The implant 500 includes at least one bone fixation feature 540 forbeing operatively attachable to a bone surface 542 of the patient, andat least one cap (or similar coverings including crowns) receivingfeature 546 (see for example, FIG. 13) for receiving one or more caps549 (and/or crowns) thereon (See FIG. 14). As shown in FIGS. 2A and 2B,the at least one bone fixation feature 540 is configured for beingfixedly attachable to the lower jawbone 16 of the patient and the atleast one cap receiving feature 546 is opposite the at least onefixation feature 540.

Now referring to FIGS. 3 and 4, a gum 522 is incised by way of anincision 555 and reflected 558 exposing the jawbone 16. A surgical guide561 is positioned on the teeth. Osteotomies 564 are drilled through thesurgical guide 561 into the jawbone 16. The surgical guide 561 isthereafter removed.

As shown in FIGS. 5 and 6, a rig 513′, such as a titanium rig, andincorporated with root-form implant 567 is then placed on the jawbone16. Fixating elements 560, such as fixating screws, are used to fixatethe rig 513′ onto the jawbone 16 on either or both the front and back ofthe jawbone. The fixating may occur in one or more places along thejawbone as appropriate. By way of example, one or more fixating screws560 may be positioned through fixation ports 561 in outer surface 573 ofthe jawbone, on the inner surface 576 of the jawbone, front-portion ofthe jawbone, and/or backside-portion of the jawbone, or any otherportion as may be necessary. One or more healing elements such ashealing screws 579 are positioned in the rig 513′. As shown in FIG. 6, aplurality of healing screws 579 are positioned on the top surface 582 ofthe rig (or the bottom surface if the rig were disposed on the upperjaw). The rig is secured in place as can be seen from FIGS. 5 and 6, onboth the outer and the inner potions of the jawbone.

Bone graft substance 590, as can be seen in FIG. 7, is placed in andaround the rig using appropriate tools such as surgical spatula 593. Inthe embodiment, as shown, the bone graft substance 590 is particularlyplaced inside the cavities/cells 515 formed by the girders 514. As shownin FIG. 7, the bone graft substance covers at least substantially theinside and the outside of the rig. The rig provides scaffold, where thebone graft will conduce bone growth. Membrane 620 is placed over, atleast a substantial portion, of the rig to cover the rig and the bonegraft substance. In the embodiment shown, the membrane at leastsubstantially covers the healing screws 579. The gum 522 is then suturedin place using sutures 625 or other similar elements.

Now referring to FIGS. 9 and 10, after passage of suitable period oftime, for example 6 months, the healing screws 579 are exposed andremoved. Healing abutments 630 are placed on the rig 513′ where thehealing screws 579 were previously located.

Now referring to FIGS. 11 and 12, after the passage of suitable periodof time, for example 1 month, the healing abutments 630 are removed andpermanent abutments 670 and crowns 549 are placed onto the rig 513′.Abutment fixating screws 673, may be used to secure the permanentabutments 670 onto the rig 513. The sutures may also be removed at thistime (or the sutures may of the disintegratable or resorbable type).

In an exemplary embodiment, similar to the method generally describedabove, features of which are generally shown in FIGS. 13 and 14, afterthe completion of steps generally shown in FIG. 4, a rig 513″incorporated with root-form implant 567″ and abutments 670″ is placed onthe jawbone 16. Fixating screws 560 are used to fixate the rig 513″ onthe jawbone. Bone graft substance 590 is placed in and around the rigsimilar to that describe in relation to FIG. 7. The rig 513″ provides ascaffold where the bone graft will conduce bone. Membrane 620 is placedon top of the rig (and the incorporated abutments“) and the bone graft.The gum is sutured in place using sutures 625. Finally the crowns 549are disposed on the abutments 670”, all during the same surgicalprocedure. The rig will eventually fuse with the jawbone over time.

Now referring to FIGS. 15A, 15B, 16A, 16B, 17A and 17B, an exemplaryimplantable device 500 is shown as disposed in a patient's mouth toreplace a missing segment of the lower jaw (mandible) which may havebeen a result of any number of circumstances such as cancer, gun shotwound, or the like.

As shown, the rig 513″, incorporated with root-form implant 567″ andabutments 670″, is disposed on the mandible bone 16, after a portion ofthe gum has been excised and reflected. Fixating screws 560 are used tofixate the rig 513″ on the jawbone. Bone graft substance 590 is placedin and around the rig similar to that describe in relation to FIGS. 13and 14. The rig 513″ provides a scaffold where the bone graft willconduce bone. Membrane 620 (not shown) is placed on top of the rig (andthe incorporated abutments“) and the bone graft. The gum is sutured inplace using sutures 625. Finally the crowns 549 are disposed on theabutments 670”, all during the same surgical procedure. The rig willeventually fuse with the jawbone over time. In the alternative, thecrowns 549 may be pre-disposed on the abutments 670″ prior to the rigbeing disposed on the jawbone. In the embodiment shown, the lowerportion of the implant may have a sufficiently large surface area inorder to provide the necessary affixation of the implant to the jawbone.

Now referring to FIGS. 18A, 18B, 19A, 19B, 20A and 20B, an exemplaryimplantable device 500 is shown as disposed in a patient's mouth toreplace missing teeth of a patient with severe to moderate bone loss onthe edentulous upper jaw 16″.

Bone Grafts

Bone grafts may be used in combination with the method and/or deviceherein. Bone grafts may also be used before and/or after the methodand/or device described herein. There are several types of bone grafts,any of which may be used at any time sequence or frame of time inreference to the present invention. Bone grafts may be used wherein thebone to be grafted to the jaw is taken, or harvested, from the patient'sown body. The area where the bone is harvested from, known as the donorsite, is usually the mouth or the hip. This is the patient's own boneand is very compatible with his/her body. Autografts are generally thebest graft technique and usually result in the greatest regeneration ofmissing jawbone.

Allografts are taken from human donors. Bone obtained in this mannerundergoes rigorous tests and sterilization. The patient's body convertsthe donor bone into the patient's natural bone, thereby rebuildinghis/her resorbed jawbone. Xenografts are harvested from animals. Theanimal bone, most commonly bovine (cow), is specially processed to makeit biocompatible and sterile. It acts like a filler which in time thepatient's body will replace with natural bone. After this replacementprocess is complete, dental implants may be placed to support the teeth.Alloplastic grafts are inert, man-made synthetic materials. The modernartificial joint replacement procedure uses metal alloplastic grafts.For bone replacement a man-made material that mimics natural bone isused. Most often it is a form of calcium phosphate. Depending on how itis made, it may be resorbable or non-resorbable. That is, the patient'sbody may or may not replace the alloplastic graft with the patient'snatural bone. In those cases where it is not replaced, it acts as alattice or scaffold upon which natural bone is built. In either case,the end result is to create enough bone for the placement of dentalimplants. Recently, recombinant human bone morphogenetic protein (e.g.,available from Medtronic Corporation) has been used to create bone byinducing the stem cells to differentiate to osteoblast (bone formingcells) to form new bone. Other types of bone grafting using recombinantDNA technology such as, for example, growth factors and/or morphogensmay also be used.

Root-Form Implants

Root-form implants may be incorporated as part or parts of the methodand/or device herein. Root form implant, when they are incorporated inthe device or rig could be partially placed inside the present bone whenthe bone volume allows to aid in the primary retention and fixation ofthe device. Root-form implants may also be used in areas adjacent towhere the device is placed before and/or after the method and/or devicedescribed herein. There are several types of root-form implants, any ofwhich may be used at any time sequence or frame of time in reference tothe present invention. Root-form implants may be the closest in shapeand size to the natural tooth root. They are commonly used in wide, deepbone to provide a base for replacement of one, several or a completearch of teeth. After application of anesthetic, the dentist will exposethe area of the jawbone to be implanted and prepare the bone to acceptthe implant. The number of incisions and bone preparations depends uponthe number of implants (and teeth) being placed. The implant iscarefully set into place and the gums are closed with several stitches.The healing period usually varies from patient to patient and can be ofany time length. For example, the healing period can be two weeks, onemonth, six weeks, two months, ten weeks, three months, fourteen weeks,four months, eighteen weeks, five months, twenty-two weeks, six months,twenty-six weeks, seven months, thirty weeks, eight months, thirty-fourweeks, nine months, thirty-eight weeks, ten months, forty-two weeks,eleven months, forty-six weeks, and a year. . During this time,osseointegration occurs. The bone grows in and around the implantcreating a strong structural support. In fact, this bond can be evenstronger than the original tooth. When healing is complete, the implantis uncovered and an extension or abutment is attached to it. Now theimplant and abutment act as a solid unit ready to support the new toothor teeth.

Plate-form implants are usually used when the bone is so narrow that itmay not be suitable for the root-form implant and the area is notsuitable for bone grafting. The plate-form implant is flat and long soit can fit into the narrow jawbone. After application of anesthetic, thedentist will expose the area of the jawbone to be implanted and preparethe bone to accept the shape of the implant. The number of incisionsdepends upon the number of implants being placed. The implant iscarefully set into place and the gums are closed with several stitches.Like root-form implants, there is usually a healing period forosseointegration, although some plate form implants are designed forimmediate restoration. The plate form implant or implants could beincorporated as part or parts of the rig. The plate form could beimplanted in the area adjacent to the area where the device is implantedbefore or after the device is implanted.

With very advanced jawbone resorption there may not be enough bone widthor height for the root-form or plate-form implant. In these cases thesubperiosteal implant may be prescribed. The subperiosteal implant iscustom made and designed to sit on top of the bone, but under the gums.There are two methods for its placement.

In the dual surgery method, after application of anesthetic, the dentistwill expose the jawbone and take an impression or model of the boneusing special materials. This model is used by a dental laboratory tocarefully create the custom implant to fit the patient's jaw. A secondprocedure is then carried out where the jawbone is exposed and theimplant placed. The gums are closed with several stitches andreplacement teeth are put into place.

In the single surgery method the dentist will order a special CAT scanof the patient's jawbone. Using the CAT scan data and advanced computermodeling techniques, a model of the jawbone is constructed. This modelis used by a dental laboratory to fabricate the custom subperiostealimplant to fit the patient's jaw. A surgical procedure is then carriedout where the jawbone is exposed and the implant placed. The gums areclosed with several stitches and the replacement teeth are put intoplace.

The foregoing disclosure of the exemplary embodiments has been presentedfor purposes of illustration and description. It is not intended to beexhaustive or to limit the invention to the precise forms disclosed.Many variations and modifications of the embodiments described hereinwill be apparent to one of ordinary skill in the art in light of theabove disclosure.

Further, in describing representative embodiments, the specification mayhave presented methods and/or processes as a particular sequence ofsteps. However, to the extent that the methods or processes do not relyon the particular order of steps set forth herein, the methods orprocesses should not be limited to the particular sequence of stepsdescribed. As one of ordinary skill in the art would appreciate, othersequences of steps may be possible. Therefore, the particular order ofthe steps set forth in the specification should not be construed aslimitations on the claims.

While the invention is susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the invention is not to be limited to the particular formsor methods disclosed, but to the contrary, the invention is to cover allmodifications, equivalents and alternatives falling within the scope ofthe appended claims.

That which is claimed:
 1. An implantable dental device, comprising: a 3dimensional trabecular meshwork structure having a plurality ofinterconnected cells, the structure having a height coextendingsubstantially along a vertical axis extending between the mandible andmaxilla, a width coextending substantially along a horizontal axisextending between facial and lingual sides, the structure configured forplacement within the patient's mouth; a plurality of root-form implantsformed integral with the meshwork structure, at least a portion of acylindrical body of at least one of the root-form implants configuredfor at least partial penetration within the jaw bone; at least onefixating surface extending along a facial surface of the structure, andextending directly from the facial surface of the structure, at leastone opening in the fixating surface, extending in a direction from thefacial to the lingual side of the patient's mouth, to receive at leastone fixating element to attach the structure to a patient's jawbone; anda plurality of prosthesis receiving surfaces, each of the prosthesisreceiving surfaces disposed adjacent a corresponding root-form implantfor receiving a corresponding number of prostheses thereon.
 2. Thedevice of claim 1, wherein at least some of the plurality of theprosthesis receiving surfaces include a corresponding abutment receivingsurface to receive an abutment thereon.
 3. The device of claim 2 whereinthe structure resembles a scaffold resulting, at least in part, inguided bone growth which is formed subsequent to the implantation,formed within at least a substantial portion of the plurality of cells.4. The device of claim 2, further comprising at least one abutmentaffixed to the corresponding abutment receiving surface.
 5. The deviceof claim 1, wherein at least a portion of the interconnected cells forma plurality of vertically aligned cells.
 6. The device of claim 5,wherein the at least one fixating surface is configured to receive atleast one threaded fixating element for operatively and fixedlyattaching the structure to a patient's jawbone, the at least onefixating element configured to engage with the jaw in a directionsubstantially perpendicular to the vertical axis.
 7. An implantabledental device, comprising: a 3 dimensional trabecular meshwork structurehaving a plurality of interconnected cells configured for receiving bonegraft material therein, the structure having a height coextendingsubstantially along a vertical axis extending between the mandible andmaxilla, a width coextending substantially along a horizontal axisextending between facial and lingual sides, a first end, and a secondend, the structure configured for permanent placement within thepatient's mouth; a plurality of root-form implants formed integral withthe meshwork structure, at least a portion of a cylindrical body of atleast one of the plurality of root-form implants configured for at leastpartial penetration within the jaw bone; at least one fixating surfaceextending directly from the facial surface of the structure forreceiving a fixating element for attaching the structure to a patient'sjawbone; and a plurality of prosthesis receiving surfaces, theprosthesis receiving surfaces disposed adjacent a correspondingroot-form implant for receiving a corresponding number of prosthesesthereon.
 8. The device of claim 7, wherein at least a portion of theinterconnected cells form a plurality of vertically aligned cells. 9.The device of claim 8, comprising at least one abutment affixed to acorresponding one of the plurality of root-form implants, the at leastone fixating surface for receiving the fixating element to accommodate athreaded fixating element which upon engagement is substantiallyperpendicular to a surface of the structure.